Glaukos Corporation

Glaukos Corporation

Director, Systems Compliance - Onsite in Aliso Viejo, CA

Aliso Viejo, CA, United States · Director · Full-time

Sponsorship not specifiedDetected 22 days ago
Cloud PlatformsCybersecurityComplianceERPFDA RegulatoryMedical DevicesLeadershipGxPRegulatory Affairs

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About the role

  • The Director provides strategic leadership for IT compliance, system validation, technology governance, audit readiness, cybersecurity compliance, and data integrity programs.
  • The role operates with significant autonomy and serves as a trusted advisor on technology risk, compliance strategy, and digital transformation initiatives.

Responsibilities

  • Lead the enterprise IT compliance and Computer System Validation (CSV) program for regulated applications, cloud platforms, infrastructure, and digital technologies.
  • Establish and maintain IT governance frameworks, policies, standards, and procedures related to system compliance, validation, cybersecurity, data integrity, and technology risk management.
  • Partner with IT Architecture, Infrastructure, Enterprise Applications, Cybersecurity, Quality, Regulatory Affairs, and business leaders to align technology strategies with compliance requirements and operational objectives.
  • Lead technology-focused audit and inspection activities, including internal audits, supplier assessments, regulatory inspections, and remediation programs.
  • Establish and monitor key compliance, cybersecurity, operational, and system performance metrics to support executive decision-making and enterprise risk management.
  • Drive adoption of modern validation methodologies, risk-based compliance approaches, automation tools, and digital quality initiatives to improve efficiency and effectiveness.
  • Build, develop, and lead a high-performing team of IT compliance, validation, and governance professionals while fostering a culture of accountability, security, innovation, and continuous improvement.
  • Proven ability to influence senior leadership and drive enterprise-wide compliance strategies in a highly regulated environment.

Requirements

  • Bachelor's degree and 12+ years of experience in Computer System Validation, Quality Systems, Information Technology Compliance, or a related regulated environment.
  • Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline required.

Nice to have

  • Advanced degree and/or relevant certifications in Quality, Compliance, Validation, or Information Technology preferred.

Skills

  • Director, Systems Compliance
  • How You'll Contribute:

Compensation

  • Relocation is available along with excellent compensation and benefits!

Benefits

  • Minimum 5+ years of leadership experience managing validation, compliance, or quality teams in the medical device, pharmaceutical, biotechnology, or life sciences industry.
  • Relocation is available along with excellent compensation and benefits!
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This listing is sourced directly from Glaukos Corporation's careers page and normalized into a canonical job model.